Product information
From Health Canada
The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.
Current status:
Marketed
Current status date:
2024-04-12
Original market date: See footnote 1
1990-12-31
Product name:
DIANEAL PD4 CAPD SOLUTION WITH 4.25% DEXTROSE AND 2.5MEQ/L CALCIUM
DIN:
00865117
Product Monograph/Veterinary Labelling:
Date:
2023-06-14
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
VANTIVE ULC
6675 Millcreek Drive, Unit 2
Mississauga
Ontario
Canada
L5N 5M4
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Haemodialysis (Intraperitoneal)
Number of active ingredient(s):
5
Schedule(s):
Ethical
American Hospital Formulary Service (AHFS): See footnote 3
40:34.00* See footnote6
Anatomical Therapeutic Chemical (ATC): See footnote 4
B05ZA HEMODIALYTICS, CONCENTRATES
Active ingredient group (AIG) number:See footnote5
0500162030
| Active ingredient(s) | Strength |
|---|---|
| CALCIUM CHLORIDE | 18.3 MG / 100 ML |
| DEXTROSE | 4.25 G / 100 ML |
| MAGNESIUM CHLORIDE | 5.08 MG / 100 ML |
| SODIUM CHLORIDE | 538 MG / 100 ML |
| SODIUM LACTATE | 448 MG / 100 ML |